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Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant

29 november 2012 uppdaterad av: Fred Hutchinson Cancer Center

Metabolic Syndrome Following Transplant for Leukemia

RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood leukemia who have undergone stem cell transplant may help doctors learn more about the disease and the long-term effects of leukemia treatment. It may also help improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone stem cell transplant.

Studieöversikt

Detaljerad beskrivning

OBJECTIVES:

  • To determine the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) and compare the extent to which prevalence is higher in HSCT survivors than in age- and gender-matched population norms derived from the Third National Health and Nutrition Examination Survey (NHANES III).
  • To evaluate the relationship between insulin resistance and risk factors associated with metabolic syndrome (e.g., hypertension, obesity, hyperinsulinemia, and dyslipidemia) as measured by euglycemic insulin clamp, fasting serum insulin, glucose, lipids (total cholesterol, triglycerides, LDL-C, and HDL-C), blood pressure and anthropometric measurements, and DEXA scan in these patients and compare to age- and gender-matched population norms.
  • To assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of metabolic syndrome and that may be altered after HSCT, including growth hormone secretion, adipokines (adiponectin and leptin), and inflammatory mediators (interleukin-6, tumor necrosis factor-α, and C-reactive protein).
  • To evaluate the association of metabolic syndrome and early signs of impaired endothelial function and cardiovascular changes.
  • To evaluate health behaviors related to prevention of cardiovascular disease, diabetes, and obesity, including a physical activity assessment, a dietary assessment, and a health knowledge assessment that will be used in the analyses of metabolic syndrome, growth hormone deficiency, and indicators of cardiovascular disease.

OUTLINE: Patients are stratified according to post-transplant follow-up period (2-9 years vs 10-15 years vs > 15 years).

Patients and their siblings undergo physical examination, a review of medical and family history, and blood pressure and anthropometric measurements. Patients and their siblings also undergo blood sample collection for laboratory studies (including analysis of C-reactive protein and CBC; lipid profile and triglycerides; leptin and adipokines; free thyroxine, TSH, IGF1, IGF3, and LH; and estradiol [females] or testosterone [males]); urine sample collection for microalbumin determination; and other study procedures (including euglycemic insulin clamp study; body composition and bone density [DEXA] study; bone-age x-ray [for patients < 18 years of age]; and vascular studies). Patients also undergo growth hormone stimulation testing.

Patients and their siblings complete questionnaires about their physical activity, dietary habits, and health knowledge.

PROJECTED ACCRUAL: A total of 193 childhood leukemia survivors and 193 healthy siblings will be accrued for this study.

Studietyp

Observationell

Inskrivning (Faktisk)

244

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Washington
      • Seattle, Washington, Förenta staterna, 98105
        • Clinical Research Center - Seattle Children's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

9 år till 21 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Childhood leukemia survivors and healthy siblings, 9-21 years of age.

Beskrivning

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Survivor of childhood leukemia, meeting all of the following criteria:

      • 21 years of age and under at diagnosis
      • Has undergone hematopoietic stem cell transplantation (HSCT) at Fairview University Medical Center or Fred Hutchinson Cancer Research Center ≥ 2 years ago
      • Disease in remission
    • Healthy sibling of a childhood leukemia survivor

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Comparison of the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) with age- and gender-matched controls
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT
Comparison of insulin resistance in patients with age- and gender-matched controls
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT
Correlation between insulin sensitivity and risk factors associated with metabolic syndrome
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT
Influence of time since transplant on insulin resistance
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT
Peak growth hormone secretion in patients with insulin resistance and in those without
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT
Growth hormone deficiency in patients with metabolic syndrome and in those without
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT
Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT
Correlation of adiponectin with insulin resistance and central obesity
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT
Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT
Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without
Tidsram: ≥2 years post-HSCT
≥2 years post-HSCT

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: K S Baker, MD, MS, Fred Hutchinson Cancer Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2005

Primärt slutförande (Faktisk)

1 juli 2011

Avslutad studie (Faktisk)

1 november 2012

Studieregistreringsdatum

Först inskickad

12 juni 2009

Först inskickad som uppfyllde QC-kriterierna

12 juni 2009

Första postat (Uppskatta)

15 juni 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

3 december 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 november 2012

Senast verifierad

1 november 2012

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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